The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Airlife Heated Ventilator And Breathing Circuits.
| Device ID | K993833 |
| 510k Number | K993833 |
| Device Name: | AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Contact | Sharon Robbins |
| Correspondent | Sharon Robbins ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-12 |
| Decision Date | 1999-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30889483584341 | K993833 | 000 |
| 30889483572553 | K993833 | 000 |
| 30889483572812 | K993833 | 000 |
| 30889483572829 | K993833 | 000 |
| 30889483572874 | K993833 | 000 |
| 30889483572997 | K993833 | 000 |
| 30889483573376 | K993833 | 000 |
| 30889483574014 | K993833 | 000 |
| 30889483584082 | K993833 | 000 |
| 30889483572522 | K993833 | 000 |